Identity
- Trade Name
- Coaxial Circuit, Adult, 180cm EUDAMEDN/A FDA UDI
- Generic Name
- Anaesthesia breathing circuit, single-use FDA UDI
- Device Name
- Disposable Anesthesia Circuit EUDAMEDDisposable Anesthesia Circuit, Coaxial Circuit, Adult, 180cm FDA UDI
- Model / Reference
- AB0299 EUDAMEDFDA UDI
- Description
- Disposable Anesthesia Circuit, Coaxial Circuit, Adult, 180cm FDA UDI
Identifiers
- Catalog Number
- AB0299 FDA UDI
- Primary DI / UDI-DI
- 06923980104435 EUDAMEDFDA UDI
- Basic UDI-DI
- 69239801ND2BANH EUDAMED
- FDA Product Code
- CAI FDA UDI
- EMDN Code
- R020102 COAXIAL BREATHING CIRCUITS EUDAMED
- GMDN Term
- Anaesthesia breathing circuit, single-use FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass I FDA UDI
- Regulation Number
- 868.5240 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Coaxial Circuit, Adult, 180cm by GaleMed (Xiamen) Co., Ltd. — Class IIa — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 69239801ND2BANH | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- GaleMed (Xiamen) Co., Ltd.
- EUDAMED SRN
- CN-MF-000020627
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (2)
- EUDAMED bf4d3a20-1a72-415b-a13b-7b120d53f83c 61 fields · synced Jul 9, 2026
- FDA UDI 658aca75-6aa7-4384-8396-7494f5c8a700 34 fields · synced May 30, 2026